Extractable and leachable (E&L) compounds associated with the use of polymeric single-use systems (SUS) are important because they have the potential to directly impact on product and patient safety. The 2014 BioPhorum Extractables Protocol provided a standardized framework to conduct extractables testing and has been widely used by SUS suppliers and end-user biomanufacturers. However, since its implementation, concerns have been raised...
BioPhorum extractables protocol
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Extractables: A comprehensive review of BioPhorum standardized extractables testing data – a deep dive into similarities, differences and trends across extraction solvents and time points
Extractable and leachable (E&L) compounds associated with the use of polymeric single-use systems (SUS) are of primary concern due to their direct impact on product and patient safety. The 2014 Biophorum extractables protocol provided a standardized framework to conduct E&L testing and has been widely used by SUS suppliers as well as the end-user biomanufacturing companies. Since its implementation, several concerns associated with the testing methods proposed in the protocol have been raised by testing laboratories. A comprehensive review of the data generated using the 2014 BioPhorum extractables protocol was initiated by Biophorum’s Extractables and Leachables workstream to mitigate these concerns.
This document aims to summarize the findings of the data review and make scientific, data-driven recommendations to address specific concerns about extraction solvents and testing timepoints. This review established that certain extraction solvents (5M Sodium Chloride and 1% Polysorbate 80) and timepoints (Time 0) proposed in the testing matrix of the 2014 protocol added limited value to determination of the full extractables profile. Such trends were
observed for organic and elemental extractables alike. Based on these findings, specific recommendations about elimination of these solvents and timepoints are outlined in this document.
The standardized extractables testing protocol provides suppliers with a set of procedures agreed upon as representative of a comprehensive range of conditions by a broad group of companies. Suppliers can use this to prepare standardized extractables test reports for single-use systems (SUS) components including, but not limited to, films, tubing, tubing connectors and disconnectors, aseptic connectors and disconnectors, sterilizing-grade and process filters, tangential-flow filter cassettes, sensors, valves, chromatography columns, impellers, and filling needles. This template supports the completion of the extractables test report.
May 2019 |
Independent industry surveys have shown that concerns about extractables and leachables are the number one barrier to implementing disposables technologies.There is clear regulatory guidance around what is required by regulatory authorities such as the EMA, yet to date there has been limited or no information (consensus or best practice) on how companies should do this.